Quality Engineer

Omega; Gloucester; On-site; GBP 36,000 - 54,000; Full time

Benefits offered by this job

Holiday entitlement 25d

Private health care

Retail discounts

Job summary

Omega is seeking a Quality Engineer to support the Quality Management System for Medical Devices on a permanent onsite basis in the United Kingdom. The role ensures compliance with ISO 13485, MDR, and applicable regulatory requirements, and drives CAPA, change control and complaint investigations.

You will analyse quality data, maintain procedures and records, and work with cross-functional teams to improve processes.

Qualifications

• Degree in engineering, medical technology or equivalent.
• Knowledge of ISO 13485 and FDA Quality System requirements.
• Experience with CAPA, non-conformances, change control and complaint investigations.

Responsibilities

• Maintain compliance with ISO 13485, MDR and applicable regulatory requirements.
• Improve CAPA effectiveness and closure timeliness.
• Analyse quality data and trends to identify improvement opportunities.
• Develop, review and update quality procedures, work instructions and records.

Skills

ISO 13485

FDA Quality System

Quality Tools

Education

Engineering / Medical technology degree

Tools

8D

CAPA

5 Why

PCDA

5S

Job description

Position: Quality Engineer (Medical Devices)

Job Type: Permanent / Onsite

My client, a global manufacturing business are on the hunt for a Quality Engineer to support all quality processes throughout the business.

Role and Responsibilities – Quality Engineer (Medical Devices)

In this role, you will be responsible for supporting and maintaining the effectiveness of the businesses QMS in accordance with ISO 13485. This will be achieved through product and process compliance through effective management of all quality activities.

Other responsibilities include:

• Maintain compliance with ISO 13485, MDR and applicable regulatory requirements
• Improve CAPA effectiveness and closure timeliness
• Analyse quality data and trends to identify improvement opportunities
• Develop, review and update quality procedures, work instructions and records.

Experience or Qualifications – Quality Engineer (Medical Devices)

• Degree educated in a relevant subject associated to engineering, medical technology or equivalent
• Knowledge of ISO 13485 Quality System and FDA Quality System requirements essential
• Experience of Quality Tools including 8D, CAPA, 5 Why, PCDA and 5S
• CAPA, non conformances, change control and complaint investigation experience

Benefits – Quality Engineer (Medical Devices)

• 25 Days + Bank Holidays
• Private Health Care Options
• Employee benefits platform for retail discounts

Candidates who currently are a Quality Engineer, QMS Engineer, Quality Assurance Engineer, Validation Engineer or Medical Device Quality Engineermay be suitable for this position.